Investigation of Efficacy and Safety of Tree MATAMPL,Tree MATA, and Placebo in Patients With Birch-Induced Seasonal Allergic Rhinitis

Exclusion Criteria

• •A patient will not be included in this study if one or more of the following criteria apply:
• •Have a positive skin prick test \[wheal (longest diameter) ≥ 3 mm greater than the negative control\] at Visit 1 to any of the following perennial allergens: house dust mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae), molds (Cladosporium cladosporioides, Alternaria alternata, Penicillium chyrsogenum (notatum), and Aspergillus fumigatus), or epithelia (cat, dog, and horse). In these cases, a careful history is to be taken and if moderate or severe symptoms are reported when exposed to the aforementioned allergens, the subject is to be excluded. Exception: the source of the allergen (cat, dog, horse) can be avoided for the entire study. Subjects with mild or no symptoms when exposed to the aforementioned allergens during the 3 years prior to Visit 1 will be allowed to enroll. Mild symptoms are defined as: sign/symptom clearly present, but minimal awareness, easily tolerated.
• •Concurrent disease that might complicate or interfere with investigation or evaluation of the study medications or the skin prick test result, such as:
• •Rhinitis medicamentosa; Large obstructive nasal polyps; Documented evidence of acute or significant chronic sinusitis, or upper respiratory tract infection as determined by the individual Investigator; Asthma, with the exception of mild intermittent asthma, to lessen confounding by asthma medications; History of hospitalization for asthma; History or presence of acute or subacute atopic dermatitis, chronic dermatitis, urticaria factitia, or urticaria due to physical/chemical influence.
• •Current diagnosis of seasonal asthma caused by tree pollen exposure.
• •Concurrent use or inadequate washout of any prohibited medication.
• •Chronic or intermittent use of inhaled, nasal, ocular, oral, intramuscular, intravenous, or potent or super-potent topical corticosteroids (as assessed by the Investigator).
• •Chronic use of long acting antihistamines and other concomitant medications (e.g., tricyclic antidepressants) that would affect assessment of the effectiveness of study drug(s).
• •Are pregnant or lactating.
• •Any systemic disorder that could interfere with the evaluation of the study medication(s).
• •Upper or lower respiratory infection requiring antibiotics within 14 days of Visit 2.
• •Diagnosis of sinusitis within 30 days of Visit 2.
• •Any ocular disorder (other than allergic conjunctivitis) including presumed infectious ocular disease (bacterial, fungal, viral, etc.), which could interfere with the evaluation of the study medication.
• •Hypersensitivity to the study drug(s) excipients.
• •Patients with active or quiescent tuberculous infection of the respiratory tract, untreated local or systemic fungal or bacterial or systemic viral infections or parasitic or ocular herpes simplex.
• •Patients who have experienced nasal septal ulcers, nasal surgery or nasal trauma within 90 days of enrollment into this study.
• •Clinical history of anaphylaxis or idiopathic anaphylaxis.
• •Patients with a clinical history of immunodeficiency, including those who are on immunosuppressant therapy.
• •Patients with an auto-immune disease (e.g. of liver, kidney, thyroid, nervous system)
• •Patients with a history of angioedema
• •Patients in whom tyrosine metabolism is disturbed, especially in the case of tyrosinemia and alkaptonuria.
• •Patients with contraindications to adrenaline.
• •Patients taking β-blockers, including eye drops, for any indication.
• •Patients taking Monoamine Oxidase Inhibitors
• •Current diagnosis of chickenpox or measles.
• •Clinical history of drug or alcohol abuse which would, at the Investigator's discretion, interfere with the patient's participation in the study.
• •Clinical history of severe or uncontrolled cardiovascular, pulmonary, hepatic, renal and/or other disease/illness that could be expected to interfere with the study.
• •Clinical history, or evidence, of nasolacrimal drainage system malfunction.
• •Study site staff or immediate relatives of study site staff or other individuals who would have access to the clinical study protocol.
• •Patient that has received TreeMATAMPL in any previous clinical trial.
• •History of immunotherapy with tree pollen extract, except if treatment was successfully completed 3 years prior to Visit 1 and SAR symptoms had reappeared prior to Visit 1.
• •Patient received treatment with preparation containing MPL during the past 12 months.
• •Participation in any other investigational study within 30 days before Visit 1 or concomitantly with this study.